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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cap, cooling (infants)
Definition Indicated for use in full-term infants with clinical evidence of moderate to severe hypoxic-ischemic encephalopathy (HIE)*. Provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE.
Product CodeMXM
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
2 2 0 1 2 0 0 0 0 0 0 0 0 0 0 0

MDR Year MDR Reports MDR Events
2016 11 11
2017 12 12
2018 14 14
2019 2 2
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Cooling 7 7
Use of Device Problem 7 7
Device Displays Incorrect Message 5 5
Fluid/Blood Leak 5 5
Device Operates Differently Than Expected 4 4
No Display/Image 4 4
Device Stops Intermittently 3 3
Adverse Event Without Identified Device or Use Problem 2 2
No Flow 2 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2
Power Problem 2 2
Unexpected Shutdown 2 2
Application Program Problem 1 1
Inability to Auto-Fill 1 1
Display or Visual Feedback Problem 1 1
Temperature Problem 1 1
Computer Operating System Problem 1 1
Fracture 1 1
Appropriate Term/Code Not Available 1 1
Mechanical Problem 1 1
Insufficient Information 1 1
Filling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 18 18
No Known Impact Or Consequence To Patient 17 17
Death 2 2
No Patient Involvement 2 2
Tissue Breakdown 2 2
Hypoxia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Natus Medical Incorporated I Nov-30-2012
2 Natus Medical Incorporated II Jun-20-2012
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